Medical Device testing and FDA approval assistance

BSR offers services for Medical Device development and testing for FDA premarket submission or marketing studies. BSR has experience with both 510K and PMA application testing for CDRH or CBER review. BSR provides independent comparative testing and substantial equivalence testing for marketing as well as FDA clearance/approval studies.

A large percentage of FDA approved and developing autologous blood (CEBR) or bone marrow (CDRH) devices were tested by BSR.

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Assay Validation

Assay Validation BSR will qualify commercial immunoassay kits when available or develop assays when one is not available for your special requirements. BSR has extensive expertise in developing, optimizing and validating Immunoassays for Research & Development, Manufacture and Clinical research (Preclinical through Phase IV clini...

Assay Development

Assay Development BSR and its experienced scientific staff provide the scientific services to efficiently develop or qualify immunologic and cell-based assays for proof-of-concept through clinical and manufacturing. BSR's strong academic base, combined with our independence and experience of working to cGMP standards, gives our clie...

Contract Cell Culture

Contract Cell Culture BSR cell culture services include primary cultures of human or animal origin as well as established cell lines. Cells are cultured for production of natural or recombinant proteins or for use in bioassays such as cell migrations, proliferation, or cytokine response.

Medical Device Testing

Medical Device testing and FDA approval assistance BSR offers services for Medical Device development and testing for FDA premarket submission or marketing studies. BSR has experience with both 510K and PMA application testing for CDRH or CBER review. BSR provides independent comparative testing and substantial equivalence te...

Flow Cytometry

Flow Cytometry Flow cytometry is an essential tool for identifying changes in rare cell populations, e.g. stem cells, and for monitoring efficacy in clinical testing. Stem cell identification and enumeration in blood, bone marrow and other tissue, Cell cycle analysis, Viability and Apoptosis determination, Intracellular cytokines, Pr...

Proof of Concept Testing

Proof of Concept Testing BSR has been instrumental in performing critical Proof-of-Concept testing for Virtual companies, Venture Capital investments, and established Pharmaceutical companies. Early experiments to independently support or discourage initial investigator enthusiasm are critical to prudent investment in a new product. ...

Forensic Science

Forensic Science BioScience Research Associates, Inc. assists in patent litigation by providing laboratory testing, as well as, expert testimony. BSR provides an array of biological, in vitro testing, for drug effect and toxicology. BSR has tested Medical Devices, Chemical compounds and Drugs with blood, bone marrow, cultured cells ...

BioSciences Research Associates | Medical Device Testing

Medical Device testing and FDA approval assistance

Services